Biotechnology Environmental Documents for Permits and Petitions

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Biotechnology Regulatory Services (BRS) prepares environmental documentation as part of its obligations under the National Environmental Policy Act of 1969 (NEPA) and the APHIS NEPA implementing regulations. Under NEPA, all Federal agencies are required to take a close look at the significance of environmental impacts arising as a consequence of agency decisions. Depending on the circumstances, BRS prepares an Environmental Assessments (EA) and/or Environmental Impact Statement (EIS) prior to making decisions about issuing permits and making decisions on nonregulated status. The procedures for EAs and EISs give the public the opportunity to submit written comments on draft EAs and EISs, so that the Agency can consider these views before publishing the final version of the EA or EIS. These environmental reviews help to inform the Agency's decisionmaking process.

The BRS decisions generally fall into two categories: (1) issuance of a permit for the introduction of a regulated article, or (2) a determination of nonregulated status (for a genetically engineered organism that will no longer be subject to the regulation (7 CFR Part 340).

Petitions for Nonregulated StatusHistorically, APHIS has prepared two documents, an EA and the Determination, when it makes a decision that a genetically engineered organism will no longer be regulated under 7 CFR 340. These documents can be obtained in a single electronic document from the link below for the “Table of petitions for nonregulated status under 7 CFR Part 340.” In some cases, APHIS prepares an EIS.